Silver Stain Reagent System
FDA 510(k) K871476 · Sigma Chemical Co.
510(k) numberK871476
Submission
- Device name
- Silver Stain Reagent System
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- April 14, 1987
- Decision date
- May 21, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LEF – Stains, Dye Powder
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
More from Sigma Chemical Co.
| 510(k) | Device | Decision |
|---|---|---|
| K933694 | Sigma Glucose ReagentCGA · Traditional | 11/04/1994SE |
| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was Silver Stain Reagent System cleared by the FDA?
Silver Stain Reagent System (K871476) received a 510(k) decision of Substantially Equivalent on May 21, 1987, 37 days after the submission was received.
What is the product code of K871476?
The FDA product code is LEF – Stains, Dye Powder, a Class I (low risk) device regulated under 21 CFR 864.1850.